Axiron

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

Clinical Trials in Hypogonadal Men

Table 2 shows the treatment emergent adverse reactions
that were reported by either > 4% of 155 patients in a 120 day, Phase 3 study
or by > 4% of 71 patients who continued to use AXIRON for up to 180 days.
These data reflect the experience primarily with a testosterone dose of 60 mg,
which was taken by all patients at the start of the study, and was the
maintenance dose for 97 patients. However, the doses used varied from 30 mg to
120 mg.

Table 2: Adverse Reactions Seen With the Use of AXIRON
in either the 120 Day Clinical Trial or in the Extension to 180 Days ( > 4%)

During the 120 day trial one patient discontinued
treatment because of affect lability/anger which was considered possibly
related to AXIRON administration. During the 120 day clinical trial there was
an increase in mean PSA values of 0.13 ± 0.68 ng/mL from baseline. At the end
of the 180 day extension clinical trial, there was an overall increase in mean
PSA values of 0.1 ± 0.54 ng/mL.

Following the 120 day study,
seventy-one (71) patients entered a two-month extension study with AXIRON. Two
patients (3%) had adverse reactions that led to discontinuation of treatment
during the period from Day 120 to Day 180. These reactions were: one patient
with application site irritation (considered possibly related to AXIRON application)
and one patient with dry skin and erythema, but not at the application site
(considered not related to AXIRON administration) and application site erythema
(considered possibly related to AXIRON administration).

No serious adverse reactions to
AXIRON were reported during either the 120 day trial, or the extension to 180
days.

Postmarketing Experience

The following adverse reactions
have been identified during postapproval use of AXIRON. Because these reactions
are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.

DRUG INTERACTIONS

Insulin

Changes in insulin sensitivity
or glycemic control may occur in patients treated with androgens. In diabetic
patients, the metabolic effects of androgens may decrease blood glucose and,
therefore, insulin requirement.

Oral anticoagulants

Changes in anticoagulant
activity may be seen with androgens. More frequent monitoring of INR and
prothrombin time is recommended in patients taking anticoagulants, especially
at the initiation and termination of androgen therapy.

Corticosteroids

The concurrent use of
testosterone with ACTH or corticosteroids may result in increased fluid
retention and should be monitored cautiously, particularly in patients with
cardiac, renal or hepatic disease.

Drug Abuse And Dependence

Controlled Substance

AXIRON contains testosterone, a
Schedule III controlled substance as defined by the Anabolic Steroids Control
Act.

Abuse

Anabolic steroids, such as
testosterone, are abused. Abuse is often associated with adverse physical and
psychological effects.

Dependence

Although drug dependence is not
documented in individuals using therapeutic doses of anabolic steroids for approved
indications, dependence is observed in some individuals abusing high doses of
anabolic steroids. In general, anabolic steroid dependence is characterized by
any three of the following:

Taking more drug than intended

Continued drug use despite medical and social problems

Significant time spent in obtaining adequate amounts of
drug

Desire for anabolic steroids when supplies of the drug
are interrupted

Difficulty in discontinuing use of the drug despite
desires and attempts to do so

Experience of withdrawal syndrome upon discontinuation of
anabolic steroid use

Last reviewed on RxList: 7/3/2014
This monograph has been modified to include the generic and brand name in many instances.